In short
Direclidine (also known by its development code NBI-1117568) is an investigational medicine that is currently being studied in adults with schizophrenia. It is a chemically synthesised substance developed by Neurocrine Biosciences Inc, and it does not yet have a marketing authorisation. The clinical trial programme includes two Phase 3 studies with a total of 983 planned participants, one of which is measuring the change in PANSS total score at Week 5.
Key points
- Direclidine is an investigational medicine with no marketing authorisation.
- It is being studied in schizophrenia in adults.
- The clinical programme includes two Phase 3 trials.
- One trial is measuring the change in PANSS total score at Week 5.
- The larger trial is assessing long-term safety and tolerability.
- Direclidine is given as a hard capsule taken by mouth.
What is direclidine?
Direclidine, also known by its development code NBI-1117568, is a chemically synthesised substance that is being investigated as a potential treatment for schizophrenia. It is being developed by Neurocrine Biosciences Inc. The substance is classified in the therapeutic area of psychiatry and psychology, specifically for mental disorders. Direclidine is an investigational substance, which means it has not yet received a marketing authorisation and is not available as a prescribed medicine.
How does direclidine work?
The available registry records and supplementary sources do not provide a detailed description of the mechanism of action of direclidine. The clinical trial programme is designed to evaluate whether direclidine can improve the behavioural and psychological symptoms of schizophrenia, but the specific molecular target or biological pathway through which it may act is not described in the provided data.
Which conditions is direclidine studied for?
- Schizophrenia — a mental disorder that can affect how a person thinks, feels, and behaves. The trials are studying direclidine in adults with schizophrenia who warrant inpatient hospitalisation, as well as in adults with schizophrenia more broadly.
How is direclidine given?
Direclidine is given as a hard capsule that is taken by mouth (oral use). The product records from the clinical trials list the pharmaceutical form as a hard capsule and the route of administration as oral. In the registered trials, the dose amounts are not reported in the registry records (listed as 00 mg).
What do the clinical trials show?
Which trials are being run?
There are two Phase 3 clinical trials registered for direclidine in adults with schizophrenia. Both trials are authorised, meaning they have received regulatory approval to proceed, and one is described in a supplementary source as currently recruiting.
What is measured in the trials?
The first trial measures the change from baseline in the PANSS total score at Week 5. The PANSS (Positive and Negative Syndrome Scale) is a standard scale used to assess the severity of symptoms in schizophrenia, including positive symptoms such as hallucinations and delusions, negative symptoms such as social withdrawal, and general psychopathology. The second trial measures the occurrence of adverse events (AEs) during an open-label treatment period, with the aim of evaluating the long-term safety and tolerability of direclidine.
Who can take part in the trials?
The trials are open to adults with schizophrenia. The first trial specifically includes adults with schizophrenia who warrant inpatient hospitalisation, meaning they require treatment in a hospital setting. The second trial is open to adults with schizophrenia more broadly. The first trial is a randomised, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either direclidine or a placebo, and neither the participants nor the researchers know which treatment is being given.
The first trial has a planned enrolment of 284 participants, and the second trial has a planned enrolment of 699 participants.
What side effects are known?
The available supplementary sources do not provide a list of side effects for direclidine. The long-term safety trial is specifically designed to collect information on the occurrence of adverse events during treatment, which will help to establish the side effect profile of the medicine.